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Found 6894 cases where Vaccine is HPV4 and Serious

Case Details

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VAERS ID: 295526 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: California  
Vaccinated:2007-10-19
Onset:2007-10-27
   Days after vaccination:8
Submitted: 2007-11-05
   Days after onset:9
Entered: 2007-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2435AA / UNK LA / -
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0012U / 1 LA / -
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2208AA / 1 LA / -
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B013AA / 6 LA / -
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0127U / 2 LA / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Ataxia, Convulsion, Headache
SMQs:, Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: LABS: CT scan WNL. MRI initially WNL. Repeat MRI revealed focal lesion in corpus callosum. MRA of neck WNL. CSF protein 118 (H), WBC 54 (H), RBC 2 (H), lymphs 92% (H), monos 8% (L). HSCRP 2.05 (H)Blood, urine & CSF cultures neg. Trach aspirate culture (+) staph aureus (not MRSA).
CDC Split Type:

Write-up: approximately 2 weeks after vaccine administration developed headache, ataxia, and seizures requiring antiepileptics, steroids, antibiotics. 11/6/07 Received vax records & pcp medical records. VAERS database updated w/same & date of vax corrected to 10/19/2007. Flu shot not on vax record but ordered on pcp note. Pcp note of 10/19 indicates patient in good health on day of vax. Returned to pcp 11/2/07 w/dizziness, fever, HA, slight cough. Dx w/viral infection. T/C to provider to clarify vax info. Received 2nd page of vax record w/flu vax info. VAERS database updated w/same. 11/30/07 Reviewed hospital medical records which reveal patient experienced HA, vomiting, ataxia & right sided spasticity. Had HA x 7 days prior to admitl w/increasing ataxia x 3 days. Admitted 11/2-11/10/2007. As preparing for LP, patient had seizure & desaturation. Intubated & admitted to PICU. Neuro consult done. Given IV antibiotics & antivirals until cultures came back neg. Extubated 11/5 & progressed well on antiseizure meds. FINAL DX: Encephalitis; ataxia; headache.


VAERS ID: 295683 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: Missouri  
Vaccinated:2007-05-01
Onset:2007-05-01
   Days after vaccination:0
Submitted: 2007-11-05
   Days after onset:188
Entered: 2007-11-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Computerised tomogram, Laboratory test, Oedema peripheral, Splenomegaly
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: computed axial; diagnostic laboratory
CDC Split Type: WAES0710USA06188

Write-up: Information has been received from a physician concerning a 25 year old female who in May 2007, was vaccinated with the first dose of Gardasil. There was no concomitant medication. about 10 days after the vaccination her foot swelled up. Then the swelling spread to her knee and shoulder. The patient had a CAT-scan done and it revealed that she had an enlarged spleen. Unknown medical attention was sought. The patient was put on high dose of Ibuprofen (manufacturer unspecified) and the condition resolved by July. The enlarged spleen and swollen foot considered to be disabling. No product quality complaint was involved. No further information is available.


VAERS ID: 295685 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2007-03-01
Onset:0000-00-00
Submitted: 2007-11-05
Entered: 2007-11-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Colitis
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific inflammation (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0710USA06540

Write-up: Information has been received from a Nurse Practitioner concerning a female with no pertinent medical history and no prior drug reactions who, in February 2007, was vaccinated with the first dose of Gardasil. There was no concomitant medication. The patient''s second dose of Gardasil was administered in March 2007. The nurse practitioner reported that the patient developed colitis after she received her second dose of Gardasil. The lot numbers were not known. As of 30-OCT-2007, the patient had not recovered from the colitis. The reporter considered the colitis to be disabling. Additional information has been requested.


VAERS ID: 295876 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Texas  
Vaccinated:2007-08-28
Onset:2007-08-29
   Days after vaccination:1
Submitted: 2007-11-07
   Days after onset:70
Entered: 2007-11-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0929U / 1 UN / UN

Administered by: Private       Purchased by: Public
Symptoms: Blood lead, Dizziness, Migraine, Pallor
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No
Current Illness: No
Preexisting Conditions: No 1/3/08-records received-PMH: Seizures during phlebotomy and hair salon.
Allergies:
Diagnostic Lab Data: MRI; EEG; Lead testing 1/3/08-records received-EEG normal. Echocardiogram normal. 24 hour Holter monitor normal.MRI brain normal.CT normal.
CDC Split Type:

Write-up: During a blood test patient went pale and had a seizure. First had them 2 or 3 a day or more than 3 times per week during period of 8/29 to 10/11. Went to ER for testing on 9/11. Started taking Topamax on 10/18. Doctor described them as migraine induced seizures. 1/3/08-records received-clinic visit 11/20/07-seen in follow up of seizures, headache and dizziness without seizure risk factors. Bradycardia. First episode was approximately 4 years ago and next was approximately 18 months ago. Starting on 8/29/07-began having frequent spells and LOC, shaking of left leg and upper extremity. All other seizures are staring lasting 1-2 minutes with LOC. Fatigued. confused afterwards. Previously had daily headache now less frequent. 1/15/2010 She still has seizures 1 to 3 a month. She is on Topamax 25mg in am and 50 mg at night. This has helped control them to 1 upt to 3 a month.


VAERS ID: 296062 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-11-02
Onset:2007-11-02
   Days after vaccination:0
Submitted: 2007-11-07
   Days after onset:5
Entered: 2007-11-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blindness
SMQs:, Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0711USA00840

Write-up: Information has been received from a registered nurse concerning a 16 year old female patient, who on 02-NOV-2007 was vaccinated with the first dose of Gardasil (lot # not provided). On 02-NOV-2007, following the vaccination and while the patient was cheerleading, she developed blindness and was unable to see anything." She was taken to the hospital via ambulance, but it was unknown if she was admitted. At the time of this report, the outcome of the event was unknown. The nurse considered developed blindness to be disabling/incapacitating. Additional information has been requested.


VAERS ID: 296064 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Georgia  
Vaccinated:0000-00-00
Onset:2007-07-01
Submitted: 2007-11-07
   Days after onset:129
Entered: 2007-11-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Diabetes
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0711USA00437

Write-up: Information has been received from a physician concerning a 20 year old female with diabetes (unspecified) who on an unspecified date was vaccinated with her second dosage of Gardasil. Since July 2007 the patient has had abdominal and periumbilical pain, possible gastroenteritis since she was given her second dosage of Gardasil. It was reported that the patient sought medical attention and was hospitalized (duration not reported). As of 01-NOV-2007, the patient had not recovered from the events. The patient''s abdominal pain and periumbilical pain were considered to be disabling by the reporting physician. Additional information has been requested.


VAERS ID: 296065 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Idaho  
Vaccinated:2007-10-12
Onset:2007-10-17
   Days after vaccination:5
Submitted: 2007-11-07
   Days after onset:21
Entered: 2007-11-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0927U / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Headache, Nausea, Paraesthesia, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown PMH: recurrent otitis media & otitis externa. Depression, self mutilation & prior suicide attempts. Childhood sexual abuse & rape w/flashbacks. Mildly obese. Allergic: sulfa. MVA 3 yrs prior w/lingering HA.
Allergies:
Diagnostic Lab Data: Unknown LABS: abnormal Pap smear 10/30. CBC, chemistry & thyroid WNL.
CDC Split Type: WAES0710USA05278

Write-up: Information has been received from a physician''s assistant concerning a 15 year old female who on approximately 17-OCT-2007 was vaccinated with a 0.5 ml dose of Gardasil. On approximately 17-OCT-2007 the patient experienced headache, extreme nausea, vomiting and tingling in fingers and toes. It was reported that the patient missed 2 days of school. At the time of the report, the patient was recovering. The reporting physician''s assistant considered headache, extreme nausea, vomiting and tingling in fingers and toes to be disabling. Additional information has been requested. 11/27/07 Received vax record from pcp. 2/8/08 Reviewed pcp medical records which reveal patient experienced URI s/s, cough, sore throat, bronchitis, otitis media & otitis externa approx 2 wks prior to vax & was on antibiotics. Seen in office 10/16 c/o HA & nausea beginning 48 hr s/p vax. Improved when seen next on 10/23 but bilat otitis externa had recurred.


VAERS ID: 296629 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: Ohio  
Vaccinated:2007-08-07
Onset:2007-08-07
   Days after vaccination:0
Submitted: 2007-11-14
   Days after onset:99
Entered: 2007-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0496U / 1 UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0524U / 2 UN / IJ
TD: TD ADSORBED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Blood glucose abnormal, Blood potassium decreased, Blood urea decreased, Dizziness, Electrocardiogram QT prolonged, Hyperhidrosis, Immediate post-injection reaction, Lymphocyte count decreased, Nausea, Neutrophil count decreased, Orthostatic hypotension, Pallor, Presyncope, Tinnitus, Tunnel vision, Vaccine positive rechallenge
SMQs:, Torsade de pointes/QT prolongation (narrow), Acute pancreatitis (broad), Agranulocytosis (broad), Haematopoietic leukopenia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Conduction defects (narrow), Torsade de pointes, shock-associated conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (broad), Cardiomyopathy (broad), Retinal disorders (narrow), Hearing impairment (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: Von Willeband''s disease
Allergies:
Diagnostic Lab Data: Electrocardiogram 10/18/07 20:23:41 QTc 471ms, sinus rhythm with sinus arrhythmia and significant QT interval prolongation with a corrected QT; 10/19/07 09:44:03 09:44:04 QTc 416ms, sinus rhythm with sinus arrhythmia normal corrected QT interval; Electrocardiography, 10/19/07, normal; cardiac exercise, 10/26/07, normal (see narrative); blood pressure, 11/13/07, 96/62; Electrocardiogram, 10/26/07 14:21:14 QTc 445, sinus rhythm with sinus arrhythmia and borderline corrected QT interval; Electrocardiogram, 10/26/07, normal; physical examination, 11/13/07; Electrocardiogram, 10/18/07 450ms, initial showed sinus arrhythmia; 11/13/07 09:43:32 QTC 416. serum blood urea, 10/18/07, 8 mg/dL, low; serum glucose, 10/18/07, 102 mg/dL, high; band neutrophil count, 10/18/07, 2%, low; segmented neutrophil, 10/18/07, 79%, high; lymphocyte count, 10/18/07, 17%, low; serum potassium, 10/18/07, 3.4 mmol/, low
CDC Split Type: WAES0711USA03379

Write-up: Patient received Gardasil vaccine in addition to hepatitis A and tetanus vaccines in August 2007. 5 minutes later became pale and diaphoretic, complained of ears ringing and tunnel vision and was presyncopal. Laid down for 15 minutes and felt better. Returned on October 17, 2007 for second dose of Gardasil. Immediately after the vaccine was uneventful. The next day became pale and diaphoretic and was presyncopal. Symptoms persisted for 5 hours and she was taken to the Emergency Room where she was found to have orthostatic hypotension. An electrocardiogram was performed which showed prolonged QT interval. Repeat electrocardiogram the next day and subsequently have shown normal QT intervals. The patient has not had prior or subsequent syncope or presyncope. This is in follow-up to report(s) previously submitted on 12/14/2007. Initial and follow-up information has been received from a physician concerning a 11 year old female who on 07-AUG-2007 was vaccinated with her first dose of GARDASIL (lot# 658094/0524U), 0.5mL injection. On 07-AUG-2007 the patient experienced syncope right after receiving the first dose of GARDASIL. The patient also received hepatitis A vaccine (inactive) the same day. On-Oct-2007 the patient received her second dose of GARDASIL (lot# 658560/1062U) and again experienced syncope. The patient also received influenza virus vaccine (unspecified) (lot# 02505AA) the same day. Subsequently, the patient recovered. Unspecified medical attention was sought. Information was received from a cardiologist and medical records. The patient was seen on 13-NOV-2007 in consultation at a request for the evaluation of recurrent presyncope and an abnormal electrocardiogram. The patient also had a tetanus vaccine. Approximately 5 minutes after administration the patient became pale and diaphoretic. The patient''s ears were ringing and the patient had tunnel vision. The patient was presyncope and laid down. The patient was symptomatically improved within 15 to 20 minutes. In October 2007, the patient was presented for a second dose of GARDASIL. The next day she had similar symptoms and had to lay down. With this episode however, the patient was symptomatic for more than 5 hours. The patient was admitted for overnight observation on 18-OCT-2007 following repeated episodes of lightheadedness, tunnel vision and nausea. The patient was taken to emergency room where she was shown to have orthostatic blood pressure changes and received IV fluid resuscitation and improvement in her symptomatology. The patient was hospitalized overnight on telemetry monitoring with no abnormalities identified. The patient''s initial ECG was on 18-OCT-2007 and demonstrated sinus arrhythmia with a QTc interval = 450ms. An electrocardiogram was performed on 18-OCT-2007 at 20:23:41 which showed sinus rhythm with sinus arrhythmia and significant QT interval prolongation with a corrected QT interval of 471 ms. On 18-OCT-2007 the patient had several tests performed. The serum blood urea nitrogen test was 8 mg/dL (low), serum glucose test was 102 mg/dL (high), the blood band neutrophil count was 2 % (low), blood segmented neutrophil count was 79% (high), blood lymphocyte count was 17% (low) and the serum potassium test was 3.4 mmol/L (low). The patient''s symptoms gradually improved, and she was discharged from the emergency room. The patient returned the next day for an electrocardiogram (19-OCT-2007 09:44:03) which showed sinus rhythm with sinus arrhythmia and normal corrected QT interval of 416ms. An echocardiogram was performed which was interpreted as being normal. The patient returned on 26-OCT-2007 for performance of an electrocardiogram at 14:21:14 which showed sinus rhythm with sinus arrhythmia and borderline corrected QT interval of 445ms. A graded exercise test was performed on 26-OCT-2007 and showed a normal treadmill time, normal systolic blood pressure response, normal maximal oxygen consumption and normal heart rate and rhythm response. Of note her QT interval was normal before, during and after exercise. The patient was not frankly syncopal during either episode. The patient has never had syncope or presyncope prior to the first episode or subsequent to the second. The patient''s past medical history was remarkable for the diagnosis of VON WILLEBRAND syndrome. The diagnosis was made when she had recurrent bloody noses and a significant bleed tonsillectomy. Her family history is remarkable for her mother carrying the diagnosis of neurocardiogenic syncope. There is no family history of anyone else with syncope or unexplained sudden death. On 13-NOV-2007 a physical examination was performed the patient was a healthy appearing young lady. Her blood pressure was 96/62 taken in the right arm in the sitting position with a small adult cuff. The patient''s chest is clear to auscultation and her heart rhythm is regular. The patient''s first and second heart sounds are both normal and there are no murmurs, rubs, clicks or gallops. The patient''s precordial activity was normal to palpation and her abdomen is soft with the liver being palpable at the right costal margin. The patient''s extremities show normal symmetric pulses without brahiofemoral delay. The patient''s electrocardiogram demonstrates sinus rhythm with sinus arrhythmia and is within normal limits for her age. The physician''s impression had two episodes of presyncope following administration of HPV vaccine. The first episode was shortly following administration of the vaccine and resolved quickly and certainly would not have raised any suspicion as being anything but neurally mediated hypotension secondary to medical intervention. The second episode is more concerning. This episode occurred the day following administration of the vaccine and the symptoms were quite prolonged. Certainly her symptoms at that time would seem to be consistent with hypotension rather than arrhythmia, but her electrocardiogram did demonstrate QT interval prolongation at that time as well. The patient''s subsequent electrocardiograms and her graded exercise test were normal. The physician does not think the patient has a congenital prolonged QT syndrome. The patient is due for a third dose of the HPV vaccine in February 2008. The physician feels he would be concerned about administering a third dose and think that the risk/benefit of this would be seriously considered. If administered the physician recommends that an electrocardiogram be performed prior to, immediately following the administration of the vaccine and the next day as well. Consideration might even be given cardiac monitoring around the time of administration. If given, the physician suggests that the next dose of the vaccine be administered on a day when she does not have to go to school that day or the next. The physician is not certain as to whether the QT interval prolongation was related to the vaccine or not and cannot definitely tie the vaccine to the hypotensive episodes either. Based on the patient''s evaluation to date from another physician, the physician does not believe that the patient has congenital long QT syndrome. No further testing is indicated at this time and is allowed to resume full activity without limitations. The mother and patient understand the importance of regular fluid and salt in her diet as well as appropriate intake at meals to prevent recurrent pre-syncope symptoms. At this point, no routine cardiology follow-up has been recommended. Additional information is not expected. Medical records are available upon request.


VAERS ID: 299724 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2007-09-27
Onset:2007-09-27
   Days after vaccination:0
Submitted: 2007-11-14
   Days after onset:48
Entered: 2007-11-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. UNK / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0710USA05575

Write-up: Information has been received from a physician concerning a 14 year old female with no pertinent medical history or drug reaction/allergies, who on 27-SEP-2007 was vaccinated with the first dose of Gardasil vaccine (0.5 mL). There was no concomitant medication. On 27-SEP-2007 the patient experienced Guillain-Barre Syndrome and was hospitalized. Hospitalization time was unknown. No further details were provided. The Guillain-Barre Syndrome was considered to be immediately life-threatening and disabling. At the time of this report, the patient was recovering.


VAERS ID: 299825 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: New York  
Vaccinated:2007-10-21
Onset:2007-10-22
   Days after vaccination:1
Submitted: 2007-11-14
   Days after onset:23
Entered: 2007-11-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR 02502AA / 3 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1266U / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Headache, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown. PMH: asthma. NKDA.
Allergies:
Diagnostic Lab Data: A magnetic resonance imaging (MRI) was performed, results not reported. Labs and Diagnostics: LP (-), CT WNL, MRI WNL, blood tests all WNL (done at previous ER visit). Urine Tox screen (-).
CDC Split Type: WAES0710USA07046

Write-up: Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). In October 2007, "about a week ago", the patient was vaccinated with a second doses of HPV rL1 6 11 16 18 VLP vaccine (yeast) 0.5 ml IM. Concomitant therapy included influenza virus vaccine (unspecified) also given on the same date in October 2007. In October 2007, about 24 hours after being vaccinated, the patient developed a headache, dizziness, and vomiting and was hospitalized. At the time of reporting, the patient had not recovered. The physician felt that the events were disabling. Additional information has been requested. 03/03/2008 MR received for DOS 11/8-11/2007 with DX: Headache Disorder, Intractable Migraine. Pt presented with 2 1/2 week hx of throbbing headache in the forehead, bitemporal, and occipital areas which began 1 day s/p flu and Gardasil vax. H/A associated with nausea, dizziness, light and noise sensitivity. Occasionally wakes from sleep with pain. Previous ER visit with normal diagnostics. PE WNL.


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